Tag:  GS 2  || Governance & Social Justice  || Human Development || Health

Why In News?

• India’s drug regulator this week began looking into concerns of potential cancer-causing substances contaminating popular acidity drug ranitidine.
• The move came over a week after the US flagged the issue to American patients, some companies have suspended sales of the product worldwide, and some have ordered recalls of the product.

Ranitidine

• Ranitidine is an over-the-counter prescription antacid used in the treatment of acid reflux and peptic ulcer diseases.
• It is popularly known through brand names like Aciloc, Zinetac, Rantac and Rantac-OD, R-Loc and Ranitin.
• It is commonly used to relieve acid-related indigestion and heartburn by decreasing stomach acid production.
• While other medicines like pantoprazole and omeprazole (omez) too treat these symptoms and are more commonly prescribed today, ranitidine is still widely used in India.
• Ranitidine is one of the oldest drugs to be used in acidity and upper intestinal ulcers and has been considered to be safer than similar other drugs like proton pump blockers.
• It is a commonly prescribed medicine for countering acidity and also on the World Health Organisation’s ‘Model List of Essential Medicines’.
• In India, a host of companies including GlaxoSmithKline, Dr. Reddy’s, Sun Pharmaceuticals sell over 180 versions of the drug. Some commonly known brands of Ranitidine are Zantac, Aztec, Giran, etc.

N-nitrosodimethylamine (NDMA)

• N-nitrosodimethylamine (NDMA) has been classified by the International Agency for Research on Cancer (IARC) as probably carcinogenic to humans.
• It is an environmental contaminant found in water and foods.
• It is the same impurity that the US FDA had investigated in blood pressure drugs valsartan and losartan over the last year.

Schedule H drugs

• Under the Drugs and Cosmetics Rules, 1945 drugs under Schedule H shall have labels displaying the texts “Rx” and “Schedule H” drug.
• Drugs under this schedule are to be sold by retail on the prescription of a Registered Medical practitioner only.

Carcinogenic Substances

• A carcinogen is any substance or radiation that promotes carcinogenesis, the formation of cancer.
• Examples: Abestos, Gamma rays, and Aflatoxin B1, which is produced by the fungus growing on stored grains, nuts, etc.

Issue

• Ranitidine is a much older medication, but it was always thought to be a very safe drug because it has less side effects than the other drugs that patients use nowadays to treat these symptoms.
• The US FDA stated in a release that it had learned that some ranitidine medicines contained “low levels” of a substance called N-nitrosodimethylamine (NDMA).
• An environmental contaminant found in water and foods, NDMA has been classified as probably carcinogenic to humans, which means it has the potential to cause cancer.
• This is the same impurity that the US FDA had investigated in blood pressure drugs valsartan and losartan over the last year.

How has India responded?

• The Drugs Controller General of India (DCGI) wrote to state regulators asking them to direct ranitidine active pharmaceutical ingredient (API) manufacturers to verify their products and take appropriate measures to ensure patient safety.
• DCGI asked states to inform him of action taken in this matter “at the earliest”.
• So far, the DCGI has not called for any halting of supplies, which means the ranitidine brands marketed in the country can continue to be sold until further notice.
• APIs are the ingredients that give a medicine its therapaeutic effect.
• According to industry sources, most of the world’s supply of the ranitidine API comes from two Indian firms — Saraca Laboratories and SMS Lifesciences.

Should consumers be worried?

• The DCGI has not clarified whether doctors and consumers in India should use ranitidine with caution, nor has the US FDA called for individuals to stop taking the drug at this time.
• Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.

How have other countries responded?

• While India and the US are still looking into the issue, regulators of around 15 countries are learnt to have called for recalls of ranitidine sold in their markets.
• These include Singapore, Canada, Italy, Denmark, Finland, Norway, Switzerland and Pakistan.

Additional Info 

https://indianexpress.com/article/explained/ranitidine-under-scanner-what-is-this-drug-and-should-indian-users-worry-6035040/

Mains  Question

What are the hazards of Ranitidine?